FN1Financial support: This study was financially supported by the Malawian-German Health Programme of the Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH and the German Federal Ministry for Economic Cooperation and Development (BMZ). The contribution by Felix Khuluza was supported by the Consortium for Advanced Research Training in Africa (CARTA). CARTA is jointly led by the African Population and Health Research Center and the University of the Witwatersrand and funded by the Wellcome Trust (United Kingdom) (grant no. 087547/Z/08/Z), the Carnegie Corporation of New York (grant no. B 8606.R02) and Sida (grant no. 54100029).

Abstract

Abstract

Substandard and falsified antimalarial and antibiotic medicines represent a serious problem for public health, especially in low- and middle-income countries. However, information on the prevalence of poor-quality medicines is limited. In the present study, samples of six antimalarial and six antibiotic medicines were collected from 31 health facilities and drug outlets in southern Malawi. Random sampling was used in the selection of health facilities. For sample collection, an overt approach was used in licensed facilities, and a mystery shopper approach in nonlicensed outlets. One hundred and fifty-five samples were analyzed by visual and physical examination and by rapid prescreening tests, that is, disintegration testing and thin-layer chromatography using the GPHF-Minilab. Fifty-six of the samples were analyzed according to pharmacopeial monographs in a World Health Organization-prequalified quality control laboratory. Seven out-of-specification medicines were identified. One sample was classified as falsified, lacking the declared active ingredients, and containing other active ingredients instead. Three samples were classified as substandard with extreme deviations from the pharmacopeial standards, and three further samples as substandard with nonextreme deviations. Of the substandard medicines, three failed in dissolution testing, two in the assay for the content of the active pharmaceutical ingredient, and one failed in both dissolution testing and assay. Six of the seven out-of-specification medicines were from private facilities. Only one out-of-specification medicine was found within the samples from public and faith-based health facilities. Although the observed presence of substandard and falsified medicines in Malawi requires action, their low prevalence in public and faith-based health facilities is encouraging.

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World Health Organization (WHO), 2016. Report of the Informal Technical Working Group on Draft Working Definitions of Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit (SSFFC) Medical Products. Fifth Meeting of the Member State Mechanism on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, 23–25 November 2016. A/MSM/5/7. Available at: http://apps.who.int/gb/ssffc/e/a_msm5.html. Accessed January 5, 2017.